Wearable medical monitoring device

ABSTRACT

A wearable monitoring device includes a plurality of cardiac sensing electrodes, a monitor, at least one motion sensor, and a controller. The plurality of cardiac sensing electrodes are positioned outside a body of a subject and to detect cardiac information of the subject. The monitor administers a predetermined test to the subject, and has a user interface configured to receive quality of life information from the subject. The at least one motion sensor is positioned outside the body of the subject and to detect subject motion during the predetermined test. The controller is communicatively coupled to the plurality of cardiac sensing electrodes, the monitor, and the at least one motion sensor, and receives and stores the detected cardiac information, the quality of life information, and the detected subject motion. The controller further communicates the stored detected subject motion and the quality of life information to a remote computer.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a Continuation of U.S. patent application Ser. No.14/175,433, titled “Wearable Medical Treatment Device,” filed on Feb. 7,2014, which is incorporated herein by reference in its entirety. U.S.patent application Ser. No. 14/175,433 is a Continuation of U.S. patentapplication Ser. No. 13/416,734 (now U.S. Pat. No. 8,649,861), titled“Wearable Medical Treatment Device,” filed on Mar. 9, 2012, which isincorporated herein by reference in its entirety. U.S. patentapplication Ser. No. 13/416,734 is a Continuation of U.S. patentapplication Ser. No. 12/833,173 (now U.S. Pat. No. 8,140,154), titled“Wearable Medical Treatment Device,” filed on Jul. 9, 2010, which isincorporated herein by reference in its entirety. U.S. patentapplication Ser. No. 12/833,173 is a Continuation-in-part of, and claimspriority to U.S. patent application Ser. No. 12/002,469 (now U.S. Pat.No. 7,974,689), titled “Wearable Medical Treatment Device withMotion/Position Detection,” filed on Dec. 17, 2007, which isincorporated herein by reference in its entirety. U.S. patentapplication Ser. No. 12/002,469 claims priority under 35 U.S.C. §119(e)to U.S. Patent Application No. 60/934,404, titled “Wearable MedicalTreatment Device with Motion/Position Detection,” filed on Jun. 13,2007. This application further incorporates by reference, in theirentireties, U.S. Pat. No. 4,928,690; 6,065,154; 5,944,669; 5,741,306;6,681,003; 6,253,099; and 5,078,134.

BACKGROUND OF THE INVENTION

1. Field of Invention

At least one embodiment of the present invention relates generally to awearable therapeutic device, and more specifically, to a wearabletherapeutic device configured to monitor or treat a subject.

2. Discussion of Related Art

Heart failure and other chronic conditions are a major health concernworldwide. Heart failure is a progressive disease with varying symptomssuch as fatigue, coughing, diminished exercise capacity, shortness ofbreath, fluid retention, swelling in the abdomen or legs, lungcongestion, and cardiac arrhythmias Heart failure can be treated, andits symptoms mitigated, by lifestyle modifications, medications,surgical procedures such as heart transplants, and mechanical therapies.These efforts can come with side effects and limited success rates.Heart failure continues to reduce the quality of life of victims.

SUMMARY OF THE INVENTION

Aspects and embodiments of the present invention are directed to awearable therapeutic and monitoring treatment device. The devicemonitors and collects health related information from the subject, anduses this information to determine if treatment is warranted, to suggestlifestyle modifications, and to adjust treatment regimens. The devicecan further include an external defibrillator to apply treatment such asdefibrillation to the subject when necessary. By monitoring a subject'sconditions in a nearly continuous fashion in essentially real time, acomprehensive medical record of the subject can also be developed on along term basis, for further treatment and analysis.

At least one aspect is directed to a wearable treatment device. Thetreatment device includes a cardiac sensing electrode, a treatmentelectrode, a user interface, and a sensor. The cardiac sensing electrodecan be positioned outside a body of the subject and can detect cardiacinformation. The treatment electrode can be positioned outside the bodyof the subject and can apply treatment to the subject. The userinterface can receive quality of life information from the subject. Thesensor can be positioned outside the body of the subject and can detectsubject activity and wellness information indicative of a generalwellness of the subject. The treatment device also includes acontroller. The controller can communicatively couple to the cardiacsensing electrode, the treatment electrode, the user interface, and thesensor. The controller receives the detected cardiac information, thequality of life information, and the detected subject activity andwellness information, and determines that treatment is to be applied tothe body of the subject based upon the detected cardiac information. Thecontroller can also adjust the treatment based on at least one of thedetected subject activity and wellness information and the quality oflife information. The treatment device can also include an alarm moduleto provide an alarm after the cardiac information is detected and beforethe treatment is applied to the body of the subject.

At least one other aspect is directed to a method of facilitating careof a subject. The method includes acts of sensing cardiac information ofthe subject, sensing subject activity and wellness information of thesubject, and receiving quality of life information from the subject. Themethod determines that treatment is to be applied to the subject basedupon the cardiac information, and adjusts the treatment based on atleast one of the detected subject activity and wellness information andthe quality of life information. The method also alerts at least one ofthe subject, a rescuer, a bystander, and a health care provider of atreatment regimen subsequent to sensing the cardiac information, andapplies the treatment to the subject subsequent to alerting at least oneof the subject, the rescuer, the bystander, and the health care providerof the treatment regimen.

At least one other aspect is directed to a method of facilitating careof a subject. The method includes an act of providing a wearabletreatment device. The wearable treatment device includes a cardiacsensing electrode and a treatment electrode. The wearable treatmentdevice also includes a user interface to receive quality of lifeinformation from the subject, and a sensor to detect subject activityand wellness information indicative of a general wellness of thesubject. The wearable treatment device also includes a controller. Thecontroller can couple with the cardiac sensing electrode, the treatmentelectrode, the user interface, and the sensor, to receive the detectedcardiac information, the quality of life information, and the detectedsubject activity and wellness information. The controller determinesthat treatment is to be applied to the body of the subject based uponthe detected cardiac information. The treatment can be adjusted underthe direction of the controller and based on at least one of thedetected subject activity and wellness information and the quality oflife information. An alarm module can provide an alarm after the cardiacinformation is detected and before the treatment is applied to the bodyof the subject.

In various embodiments, the alarm module can provide a second instanceof the alarm after the treatment is applied to the body of the subject.The user interface can prevent application of the treatment to the bodyof the subject. In one embodiment, the treatment device includes asecond sensor. The second sensor can be positioned outside the body ofthe subject and can detect subject activity and wellness information.The controller can determine that the treatment device is properlypositioned on the subject based at least in part on a position of thefirst sensor and a position of the second sensor.

In some embodiments, the controller can provide at least one of thecardiac information and the subject activity and wellness information toa computer server via a network. The controller can also generate areport based on the cardiac information and the subject activity andwellness information. The report may suggest a change in at least one ofa treatment regimen, an exercise regimen, and a diet regimen.

In various embodiments, a wearable treatment device is provided thatincludes a cardiac sensing electrode, a treatment electrode, a userinterface, a sensor; and a controller. The cardiac sensing electrode andthe treatment electrode are positioned outside the subject. The sensoris positioned to detect the subject activity and wellness information ofthe subject, and the user interface receives the quality of lifeinformation. In some embodiments, the wearable treatment devicesubstantially continuously senses at least one of cardiac informationand subject activity and wellness information, and provides at least oneof the cardiac information and the subject activity and wellnessinformation to a computer server via a network. The wearable treatmentdevice can also generate a report based on the cardiac information andthe subject activity and wellness information, or suggest a change in atleast one of a treatment regimen, an exercise regimen, and a dietregimen.

In some embodiments, instructions are provided to operate the wearabletreatment device. The instructions include at least one instruction toposition at least one of the cardiac sensing electrode and the sensor onthe subject. The instructions can also include at least one instructionto position the wearable treatment device on the subject.

In one aspect of the present invention, a wearable monitoring device isprovided comprising a plurality of cardiac sensing electrodes configuredto be positioned outside a body of a subject and to detect cardiacinformation of the subject, a monitor configured to administer apredetermined test to the subject and having a user interface configuredto receive quality of life information from the subject, at least onemotion sensor configured to be positioned outside the body of thesubject and to detect subject motion during the predetermined test, anda controller communicatively coupled to the plurality of cardiac sensingelectrodes, the monitor, and the at least one motion sensor, thecontroller configured to receive and store the detected cardiacinformation, the quality of life information, and the detected subjectmotion, and to communicate the stored detected subject motion and thequality of life information to a remote computer. In one embodiment, thequality of life information identifies at least one of a fatigue leveland a breathing level of the subject. In another embodiment, the qualityof life information identifies information about at least one of thesubject's lifestyle, body weight, blood pressure, eating and exercisehabits, symptom information, fatigue information, breathing level andhow the subject currently feels. In an alternative embodiment, thepredetermined test is a six minute walk test.

In another embodiment, the at least one motion sensor includes at leastone accelerometer. In one embodiment, the controller determines adistance travelled by the subject during the six minute walk test basedupon the detected subject motion from the at least one accelerometer. Inone embodiment, the device further comprises at least one additionalsensor communicatively coupled to the controller to detect at least oneof blood pressure, blood oxygen level, respiration, and temperature. Inone embodiment, the controller wirelessly communicates the storeddetected subject motion and the quality of life information to theremote computer. In another embodiment, the at least one motion sensorincludes a pedometer, and the controller determines a distance travelledby the subject during the six minute walk test based upon the detectedsubject motion from the pedometer.

In one embodiment, the monitoring device further comprises at least oneadditional sensor communicatively coupled to the controller to detect atleast one of blood pressure, blood oxygen level, respiration,hypovolemia, and temperature. In one embodiment, the quality of lifeinformation further includes information about at least one of thesubject's lifestyle, body weight, blood pressure, eating and exercisehabits, symptom information, fatigue information, and how the subjectcurrently feels. In one embodiment, the predetermined test is a sixminute walk test, and wherein the at least one motion sensor includes atleast one accelerometer. In an alternative embodiment, the devicefurther comprises at least one additional sensor communicatively coupledto the controller to detect at least one of blood pressure, blood oxygenlevel, respiration, hypovolemia, and temperature. In yet anotherembodiment, the predetermined test is a six minute walk test, andwherein the at least one motion sensor includes a pedometer.

In one embodiment, the predetermined test is a six minute walk test, andthe at least one motion sensor includes at least one of an accelerometerand a pedometer. In one embodiment, the user interface is configured toguide the subject through the predetermined test. In one embodiment, thedevice further comprises at least one additional sensor communicativelycoupled to the controller to detect at least one of blood pressure,blood oxygen level, respiration, hypovolemia, and temperature. Inanother embodiment, the quality of life information identifies a fatiguelevel and a breathing level of the subject.

In one embodiment, the quality of life information is received from thesubject in response to questions posed to the subject via the userinterface of the monitor. In one embodiment, the quality of lifeinformation is received from the subject in response to questions posedto the subject via the user interface of the monitor. In one embodiment,the questions are posed to the subject at selectable intervals. Inanother embodiment, the user interface is configured to guide thesubject through the predetermined test. In an alternative embodiment,the user interface is configured to prompt the subject to perform thepredetermined test.

In one embodiment, the user interface is configured to prompt thesubject to provide the quality of life information. In one embodiment,the device comprises at least one additional sensor communicativelycoupled to the controller to detect the subject's body position. In oneembodiment, the device comprises detecting the subject's body positionin one of an upright position and a prone position, and detecting thatthe subject is asleep. In another embodiment, the device furthercomprises at least one additional sensor communicatively coupled to thecontroller to detect at least one of sleep apnea, wheezing, andcoughing.

In an alternative embodiment, the monitoring device comprises at leastone additional sensor communicatively coupled to the controller tomeasure impedance of the subject's thoracic cavity. In one embodiment,the quality of life information identifies compliance with a prescribedtreatment. In another embodiment, the quality of life informationidentifies nutritional content of a food item, wherein the userinterface further comprises a bar code scanner configured to scan a barcode of a food item, and wherein the controller is further configured toaccess information about the nutritional content of the food item withreference to the bar code.

Other aspects, embodiments, and advantages of these exemplary aspectsand embodiments are discussed in detail below. Both the foregoinginformation and the following detailed description are illustrativeexamples of various aspects and embodiments, and are intended to providean overview or framework for understanding the nature and character ofthe claimed aspects and embodiments. The accompanying drawings areincluded to provide illustration and a further understanding of thevarious aspects and embodiments, and are incorporated in and constitutea part of this specification. The drawings, together with the remainderof the specification, serve to explain the described and claimed aspectsand embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are not intended to be drawn to scale. In thedrawings, each identical or nearly identical component that isillustrated in various figures is represented by a like numeral. Forpurposes of clarity, not every component may be labeled in everydrawing. In the drawings:

FIG. 1 depicts a diagrammatic representation of treatment devicepositioning on a subject in accordance with an embodiment;

FIG. 2 depicts a block diagram of a treatment device in accordance withan embodiment;

FIG. 3 depicts a block diagram of a treatment device in accordance withan embodiment;

FIG. 4 depicts a block diagram of a treatment device in accordance withan embodiment;

FIG. 5 depicts a flow chart for a method of monitoring and treating asubject in accordance with an embodiment;

FIG. 6 depicts a flow chart for a method of monitoring and treating asubject in accordance with an embodiment; and

FIG. 7 depicts a flow chart for a method of monitoring and treating asubject in accordance with an embodiment.

DETAILED DESCRIPTION

The systems and methods described herein are not limited in theirapplication to the details of construction and the arrangement ofcomponents set forth in the description or illustrated in the drawings.The invention is capable of other embodiments and of being practiced orof being carried out in various ways. Also, the phraseology andterminology used herein is for the purpose of description and should notbe regarded as limiting. The use of “including” “comprising” “having”“containing” “involving” and variations thereof herein, is meant toencompass the items listed thereafter, equivalents thereof, andadditional items, as well as alternate embodiments consisting of theitems listed thereafter exclusively.

Various aspects and embodiments are directed to a wearable treatmentdevice that senses information about a subject's condition. Thisinformation includes cardiac information, subject activity and wellnessinformation, and subject quality of life information. This informationcan be aggregated into reports on the subject's condition that can beused to provide or adjust treatment regimens. An alarm module canindicate that treatment has been, is being, or will be applied.

FIG. 1 illustrates wearable treatment device 100 configured for asubject to wear as a garment. The subject includes a person receivinghealth care, such as a subject who may or may not be under supervisionof a doctor or health care provider. The subject may be in or out of ahospital setting, and the subject can engage in day to day lifeactivities, at home, work, leisure, and play while wearing treatmentdevice 100. Treatment device 100 includes monitoring, treatment and datatransmission and processing capability, and can be worn as a vest, belt,shirt, or series of straps, garment, or undergarment for example.Treatment device 100 may include at least one power supply such as abattery, or other power supplies, including AC power supplies anduninterruptable power supplies. Treatment device 100 can monitor andtreat cardiac ailments such as heart failure, as well as other medicalconditions such as arrhythmias, pulmonary ailments, other heartirregularities, sleep disorders, and circulatory system deficienciessuch as blockages.

In one embodiment, treatment device 100 includes dedicated control logicdevices that collectively constitute a control system, such as at leastone controller 105. Controller 105 can include programmable logicdevices and arrays, application specific integrated circuits, hardwareand software combinations, general purpose processors and dedicatedcontrollers, for example. Further, treatment device 100 may includegraphical user interfaces or other interfaces to provide outputinformation and receive input information from a user. Controller 105can be contained entirely within treatment device 100, or at leastpartially located external to treatment device 100, such as at a remotecomputer server in a doctor's office, data center, or other location. Inone embodiment, controller 100 includes at least one processor asdescribed in commonly owned U.S. patent application Ser. No. 12/833,096,entitled “System and Method for Conserving Power in a Medical Device,”filed on Jul. 9, 2010, which is incorporated by reference herein in itsentirety. The referenced application generally discloses a processingarchitecture configured to conserve energy.

Treatment device 100 can also include a plurality of sensors 110, 135.The plurality of sensors 110, 135 may include subject medical conditionsensors 110, such as cardiac sensing electrodes, and subject activitysensors 135, such as motion sensors or accelerometers. While fourexternal medical condition sensors 110 are illustrated in FIG. 1,treatment device 100 can include more or less than four external medicalcondition sensors 110, and in some embodiments, sensors 110 include atleast one internal sensor or external dry electrode. Sensors 110 mayinclude at least one cardiac sensing electrode to detect a subject'scardiac information related to the subject's heartbeat or electricalactivity of the subject's heart. Sensors 110 are configured forplacement proximate to the subject, for example, about the subjectstorso, chest, back, limbs, or neck, where they can sense informationabout the subject's bodily functions. In one embodiment, sensors 110include a fingertip pulse oximeter that can generate aphotoplethysmograph to measure blood flow, blood oxygen saturation,respiration, or hypovolemia. In other embodiments, sensors 110 caninclude sensors that monitor or measure wellness information indicativeof a general wellness of the subject, such as pulse, breathing,temperature, blood pressure, or fatigue information, for example.

In one embodiment, the plurality of sensors 110, 135 includes subjectactivity sensors 135. In one embodiment, subject activity sensors 135can include at least one accelerometer to detect subject movement, lackthereof, or positional orientation. Sensors 110, 135 that includesubject activity sensors generally detect tangible medical or physicalcondition or information indicative of a subject's overall health, aswell as statistically significant changes in measurements or conditionswith time that may indicate changes in the subject's health, such as aworsening heart failure condition.

Treatment device 100 may also include at least one treatment electrode115. In one embodiment, treatment electrode 115 is configured to delivershocks or electric current to the subject, such as a defibrillationshock applied to resuscitate a subject during cardiac arrest or anothercardiac event. Treatment electrodes 115 may be housed in therapy padsthat also include receptacles to house conductive fluid such asconductive gel. For example, treatment electrodes 115 may include drytreatment electrodes. In this example, prior to treatment, controller105 can direct the receptacle to burst, releasing conductive fluid thatcontacts a surface of treatment electrode 115 as well as the subject'sskin, enhancing the electrical connection between the subject andtreatment electrode 115. The receptacles can be replaced after use.

In one embodiment, treatment electrodes 115 are formed from plates ofmetal or other conductive material having a conductive surface andconfigured for contact with the subject. The therapy electrodes may havegenerally circular, oval, rectangular, square, or other geometric formswith a generally continuous surface. In some embodiments, treatmentelectrodes 115 are formed from conductive wire or thread sewn intotreatment device 100 in stitched, woven, or intertwined patterns,including a mesh pattern. In one embodiment, treatment device 100includes at least one node 120 to connect or interface with sensors 110and treatment electrodes 115. Node 120 may be located on a belt oftreatment device 100 and can be part of or associated with controller105 to facilitate communication between controller 105, sensors 110, 135and treatment electrodes 115. In one embodiment, node 120 is a device tophysically couple cables 125 that connect controller 105, sensors 110,135 treatment electrodes 115, and other treatment device 100 components,such as at least one monitor 130. FIG. 1 depicts three treatmentelectrodes 115, with one treatment electrode positioned proximate to thesubject's chest, and two treatment electrodes 115 positioned proximateto the subject's back. This configuration can be used to provide shocksto the subject's heart during defibrillation treatment. Otherconfigurations and positions of treatment electrodes 115 are possiblefor defibrillation and other treatments.

In one embodiment, treatment device 100 includes at least one subjectactivity sensor 135. For example, subject activity sensor 135 mayinclude at least one accelerometer that can indicate accelerating anddecelerating movements. For example, a subject wearing treatment device100 can participate in normal activities, such as standing, walking,sitting, running, and generally moving about as part of day-to-day lifewhen partaking in physical, labor, and leisure activities. Because ofthe nature of human movements, generally comprising short distance andshort duration, accelerometers provide useful information about subjectmovement and activity. Controller 105 can use this information todetermine if treatment is necessary or should be adjusted, if quality oflife recommendations should be made to the subject (e.g., a suggestionto change dietary or activity habits,) or if a doctor should beconsulted. In some embodiments, activity sensors 135 include single axisaccelerometers as well as multi-axis sensors.

In one embodiment, the plurality of sensors 110, 135 include at leastone cardiac sensing electrode 110, a subject activity sensor 135, suchas an accelerometer, or other sensor configured to provide informationto controller 105 relating to the subjects cardiac information (e.g.,ECG), or activity wellness (e.g., motion or position). For example,sensor 135 can sense and provide information about the subject's bodystate—e.g., vertical, horizontal, lying down on left side, lying down onright side, moving in a recitative pattern, vibrating due toenvironmental causes such as during a car ride, convulsing due to healthcauses such as a cardiac event or seizure, accelerating, decelerating,falling, and treatment device 100 component acceleration or mechanicalshock, (e.g., sensor 135 disconnects from the subject and falls orimpacts the ground or a hard surface due to gravitational or otherforces).

In one embodiment, treatment device 100 includes two activity sensors135, such as accelerometers. For example, a first accelerometer can belocated on node 120 and a second accelerometer can be located on monitor130. In one embodiment, the first accelerometer is positioned on thesubject's upper body, and the second accelerometer 135 is positionedproximate to the subject's waist. Accelerometers or other activitysensors 135 may also be positioned on the subject's limbs. Activitysensors 135, including accelerometers, may include at least oneposition, force, or motion detector. In one embodiment, controller 105uses information detected by multiple activity sensors 135, such asaccelerometers to determine and predict subject activity, and tocalibrate or verify the accuracy of sensors 110 and/or sensors 135. Forexample, one or more of sensors 110 may be tasked with determining thesubject's heart beat, and may shift due to movement or be improperlypositioned so that an inaccurate reduced heartbeat is sensed. In thisexample, activity sensors 135 may indicate that the subject isexercising and where an elevated heartbeat would be expected, whilesensor 110 detects a reduced heart beat or no heart beat because it isimproperly positioned on the subject. Controller 105 can identify thisdiscrepancy and notify the subject, for example by a display on monitor130, that one of sensors 110 should be repositioned. By processingsensed information and information received from the user, controller105 may also determine that treatment device 100 components have beentampered with or damaged, and monitor 130 can display a notification ofany such tampering or damage. In one embodiment, controller 105 islocated together with monitor 130.

In one embodiment, controller 105 evaluates activity sensor 135information to determine the position of the subject and anycorresponding applied forces. For example, activity sensor 135 canmeasure x, y, and z axis orientations of the subject. Controller 105 canuse this information in a confidence based arrhythmia detectionalgorithm to accelerate or delay the timing of treatment based on pastand present body motion or position history. Multiple activity sensors135 permit separate evaluation of different subject movements andcontroller 105 evaluates subject movements to determine subjectactivity, create a real time and comprehensive subject medical record,and to recommend, apply, or adjust treatment regimens. The treatmentapplied can depend upon the diagnostic requirement of the subject'sdoctor and the condition of the subject (e.g., heart failure orcongestive heart failure) that the doctor or the subject wishes tomonitor.

In one embodiment, activity sensors 135 include at least oneaccelerometer to sense high sensitivity subject activity and wellnessinformation, such as breathing or other generally subtle forms of motionsuch as body position (e.g., standing or prone). Sensors 110, 135 candetect and monitor physical activity and activity trends, bodypositions, and sleep conditions, such as sleep apnea. For example, sleepapnea may be deduced based on pulse oximetry and respirationmeasurements. Sensors 135 can also include at least one accelerometer tomeasure low sensitivity data such as mechanical shock.

In some embodiments, activity sensors 135 include at least onemulti-axis accelerometer, or two three-axis accelerometers with one ofthe accelerometers mounted on a vest portion of treatment device 100 andanother of the accelerometers mounted elsewhere on treatment device 100,such as a strap about the waist, or on monitor 130, which can include avisual display where the orientation of the visual display is controlledby the output of accelerometer.

In one embodiment, treatment device 100 includes at least one monitor130, which can include at least one touch screen, buttons, or other userinterface such as a keyboard. The user interface may have multilingualaudio and visual displays. Monitor 130 can also be remote from treatmentdevice 100. Monitor 130 can display information to indicate thattreatment device 100 is or is not properly configured about the subject.For example, monitor 130 can indicate that sensors 110, 135 are properlypositioned and operational. Monitor 130 can attach to a belt or otherportion of treatment device 100. In one embodiment, monitor 130 can beexposed, external to the subject's clothing, with at least some othertreatment device components (e.g., sensors 110, 135) concealed beneaththe subject's clothing In one embodiment, treatment device 100 includestwo monitors 130, with a first monitor housed on treatment device 100,and a second monitor remote to treatment device 100. The second monitorcan communicate with controller 105. In one embodiment, the secondmonitor displays additional information that the first monitor does notdisplay. For example, the second monitor can be part of a base stationor a battery charger that includes a processor and memory. The secondmonitor can also be a personal computer monitor, (e.g., laptop, desktop,tablet, or mobile telephone monitor) configured to display the subject'shistorical medical record and other long term non-critical information,and the first monitor can be a dedicated application specific monitorthat is housed on a belt of treatment device 100 configured to input andoutput core data related to the subject's present cardiac condition,general wellness, quality of life, and treatment regimen.

In one embodiment, monitor 130 displays medication reminders to promptthe subject to take medication. For example, monitor 130 can displayvisual information (that can be supplemented with audio information)telling the subject what medication to take, and when. In oneembodiment, monitor 130 shows the subject what the medication (e.g., apill) looks like (for example, by color, shape, markings, etc.), andissues a verbal prompt to remind the subject to take a certainmedication and a certain time. After taking the medication, the subjectcan inform treatment device of this fact via a user interface of monitor130. Monitor 130 may also include an alarm module. The alarm module canbe audio, visual, tactile, or haptic, and can alert the subject as wellas bystanders that treatment device 100 has applied, is applying, orwill apply electric current or other treatment to the subject. The alarmmodule can also provide indicators of the subject's condition, such asheart or respiration rates, volume, or timing, or the subject's pulse,as well as heart failure indicators and coronary sounds.

In one embodiment, the alarm module provides an alarm after sensor 110detects cardiac information about the subject, and before treatmentdevice 100 applies treatment to the subject. The alarm module can alsoprovide a further alarm after treatment has been applied to the subject.For example, the alarm module can alert first responders that at leastone defibrillation shock has already been applied by treatment device100. The alarm module can also alert bystanders or rescuers that it issafe to contact the subject after treatment has been applied, or thatanother round of treatment (e.g., another shock) is forthcoming In oneembodiment, the alarm module indicates that treatment will be applied.When the subject does nothing to abort the forthcoming treatment (suchas depressing an abort switch or entering instructions via the userinterface,) controller 105 can instruct treatment device 100 toadminister an electric shock to the subject via one of treatmentelectrodes 115.

In FIG. 1, a first activity sensor 135 such as an accelerometer islocated in front of the subject, for example attached to monitor 130,and a second activity sensor 135, such as an accelerometer is located inback of the subject, for example attached to a belt of treatment device100. Other configurations of accelerometers are possible, in front, inback, and on the sides of the subject, and attached to different belts,straps, or other components of treatment device 100. Wire 125 allowscommunication and data transfer between activity sensor 135, medicalcondition sensors 110, and controller 105 via node 120.

FIG. 2 depicts a block diagram of treatment device 100. As illustratedin FIG. 2, controller 105 includes a microcontroller and a systemcomputer, with the microcontroller associated with node 120 and thesystem computer associated with monitor 130, and with wire 125connecting the microcontroller with the system computer. Differentconfigurations are possible. For example, more than one logic device cancollectively constitute controller 105, and controller 105 may be partof treatment device 100. In one embodiment, at least some logic devicesof controller 105, such as the system computer, are located external totreatment device 100. For example, both monitor 130 and the systemcomputer can be separate from treatment device 100. Such externalcomponents may communicate with the microcontroller or other elements ofcontroller 105 that are part of or housed on treatment device 100 viawire 125 or other connections, both wired and wireless. In oneembodiment, the microcontroller process real time information related tothe subject's cardiac information, quality of life, general wellness,and treatment regimen; and the system computer processes informationrelated to the subject's long term medical history. For example,controller 105 can provide information to a remote computer via awireless transmission to generate a comprehensive real time medicalhistory of the subject when, for example, the subject wears treatmentdevice 100 for any period of time. This medical history information maybe stored in memory that is part of treatment device 100, or remotely,for example in a hard drive of a computer in a doctor's office. Thesystem computer and the microcontroller can exchange information andinstructions regarding treatment application and adjustment. In oneembodiment, controller 105 communicates a message to a physician,responder, bystander or the subject to indicate that treatment isimminent, being provided, or has already been provided.

In one embodiment, controller 105 communicates with a central serverthat is external to treatment device 100. For example, sensed indicatorsof heart failure can be wired or wirelessly downloaded to a centralserver for processing, and presented to a doctor for review andanalysis. This information can be tailored to a doctor's needs, forexample to generate alerts and notifications. With respect to datagathering, reference is made to U.S. Pat. No. 6,681,003, entitled “DataCollection and System Management for Patient-Worn Medical Devices,”filed on Jul. 16, 2002, which is assigned to the assignee of the presentapplication and incorporated herein by reference in its entirety. Thereferenced application generally discloses remote transmission andcollection of data received from patient-worn medical devices.

In one embodiment, a first activity sensor 135, such as anaccelerometer, is attached to node 120 and a second activity sensor 135,such as another accelerometer, is attached to monitor 130. Sensedinformation from both of these sensors 135 can be transferred tocontroller 105, which can be physically attached to treatment device100, or remote from treatment device 100. In one embodiment, treatmentdevice 100 includes two accelerometers to determine parameters such assubject body position, body movement, and body acceleration, and toperform self-diagnostics. Monitor 130 can contain either a high-G or alow-G accelerometer, or both. In one embodiment, a high-Glow-sensitivity accelerometer can detect subject and equipment physicalshock to determine if treatment device 100 is damaged. Activity sensors135 can detect movement and orientation of the subject. In oneembodiment, controller 105 processes information from two activitysensors 135, such as accelerometers 135 to identify subject activity.Processing of accelerometer data can be performed by the microcontrolleror the system computer. Accelerometers can indicate change in thesubject's velocity. For example, the subject can have an activity levelwhen conscious that includes changes in both velocity and direction. Bycontrast, an unconscious subject may have little or no change in bodymotion. Other activity sensors 135 (e.g., gyroscope, magnetometer,hall-effect devices, pedometers, global positioning systems, and otherforce motion or position sensors) can indicate motion or lack of motion.Outputs from sensors 135 may be integrated, compared or differentiatedby controller 105 to predict subject activity, and reduce interferenceor error signals.

FIG. 3 depicts a block diagram of a treatment device 100. In oneembodiment, AC or DC power supply 305 (e.g., a power cord to AC mainlines, or a battery) can power treatment device 100 components, such ascontroller 105, monitor 130, and sensors 110, 135. At least one powerregulator 310 can control the power from power supply 305.

In one embodiment, controller 105 controls various system parameterssuch as activity sensor sensitivity, multiplexer (MUX) 315 channelselect, the analog to digital converter (ADC) 320, and serialcommunication with controller 105 via serial communication bus 325 toacquire data from activity sensors 135 and to display this informationat monitor 130. MUX 315 and ADC 320 can be internal to controller 105,or can be separate components. In one embodiment, activity sensors 135include a Freescale Semiconductor MMA7260Q three axis low-gmicromachined accelerometer. The g-select control line 330 coupled tocontroller 105 and the accelerometer allows the sensitivity to be variedfrom, for example, 1.5 g to 6 g. A high-G low sensitivity accelerometercan also be used to allow subject/equipment shock to be detected.Resistor-capacitor (RC) filter 335 can connect to outputs of theaccelerometer to minimize clock noise from the accelerometer internalswitched capacitor filter circuit. Controller 105 can control selectlines of multiplexor 315 and may allow each axis output of theaccelerometer to be switched to the Analog to Digital Converter (ADC)320 input. Controller 105 can also control ADC 320 via a serialinterface. In one embodiment, sensors 110, 135, controller 105, andmonitor 130 sense, process, and display other information such as sensedcardiac information, sensed general wellness information, and subjectinputted self assessment entries including quality of life information.

FIG. 4 depicts an alternative block diagram of a treatment device 100where controller 105 acquires information from activity sensor 135, suchas an accelerometer. Power supply 305 can be used to power thecomponents of treatment device 100. Activity sensor 135 can include aFreescale Semiconductor MMA7260Q three axis low-g micromachinedaccelerometer. Controller 105 controls the g-select lines that again canallow the sensitivity to be varied from, for example, 1.5 g to 6 g. RCfilter 335 as well as amplitude scaling can be applied to each of theaccelerometer outputs. In one embodiment, MUX 315 and ADC 320 areinternal to controller 105 the analog outputs of the accelerometer areinterfaced digitally directly to the controller 105.

In one embodiment, controller 105 detects an arrhythmia by assigningvarious confidence coefficients or weighting values to the varioussensors 110, 135) that communicate with controller 105. In oneembodiment, this is done prior to controller 105 determining aconfidence level that detected motion indicates true motion, and not afalse positive motion indication due, for example, to an incorrectlyplaced or dropped activity sensor 135. For example, controller 105 canseparately analyze two independent ECG data streams from sensors 110 toextract heart rate, morphology, frequency information, general wellness,and other information. Controller 105 can perform additional analysis,independently on each channel, to analyze the signal for noisecontamination that may result from subject motion or biological signalssuch as muscle noise. Secondary inputs to the basic detection algorithmcan include a subject response button or override switch, where forexample the subject indicates that they are in motion, and inputs fromactivity sensors 135. In one embodiment, controller 105 determines thatthe lack of response from the subject, for example, by not pressing asubject response button (e.g., an abort switch,) that can be part oftreatment device 100, means that the subject is unconscious.

In one embodiment, a weighting value is assigned to each sensor 110, 135and the response button to make the decision that a treatable arrhythmiacondition exists. In addition, the weighting values can be used tomanipulate or adjust the timing and nature of therapy delivered bytherapy electrodes 115.

During use by a subject, there may be instances where a first ECGchannel contains noise and a second ECG channel is clean. For exampletwo pairs of sensors 110 can independently obtain ECG signals, with onepair being contaminated with artifacts and the other being clean. Thetwo ECG signals can be obtained simultaneously or sequentially, and canbe transmitted to controller 105 via the same or different communicationchannels (e.g., wire 125). In one embodiment, controller 105 places moreweight on the clean ECG channel For example, to enhance a confidencelevel of the sensed information, a weighting can be assigned that woulddelay delivery of treatment by treatment electrodes 115 while sensors135 and controller 105 determine if there is subject motion.

The flow diagram in FIG. 5 shows that if subject motion is detectedprior to the detection of a treatable arrhythmia, the timing oftreatment delivery can be modified based on activity sensor 135 inputswhen the arrhythmia is detected. If the subject becomes motionlesscoinciding with the arrhythmia detection, there is an increasedconfidence that the arrhythmia diagnosis is accurate and the delivery oftreatment can occur sooner. If motion continues after the arrhythmiadetection, the confidence of a valid detection can be decreased becauselethal arrhythmias generally result in a lack of consciousness and lackof motion. In this case, the delivery of treatment can be delayed toallow time for audio voice messages to prompt the subject to respond bypressing the response button. The response button provides aresponsiveness test input to the algorithm. In some embodiments, it maybe desirable to never deliver a shock to a conscious subject. Thismethod can reduce the possibility of false treatment based on invalidrhythm diagnosis due to corrupt ECG inputs caused by excessive subjectmovement or other environmental factors.

FIG. 5 illustrates arrhythmia detection with increased confidence byserially feeding through a subsequent confidence algorithm using inputfrom activity sensor 135, such as a motion detector or accelerometer.Other motion detecting devices or confidence algorithms can use variousmotion detection criteria as desired by physicians and based upon thetreatable condition or subject. The motion data can also be stored,tracked and evaluated, for example to evaluate a subject's historicalmotion or activity levels to detect conditions such as congestive heartfailure. Such diseases can be found in subjects wearing treatment device100. In one embodiment, treatment device 100 includes sensors 110 tomonitor the subject's cardiac information. For example sensors 110 caninclude cardiac sensing electrodes that are positioned external to thesubject to detect the subject's cardiac information. Controller 105processes the sensed cardiac information to detect life-threateningarrhythmias, and can instruct treatment electrodes 115 to delivertreatment, such as a cardioverting or defibrillating shock. Treatmentdevice 100 can also include a user interface to receive quality of lifeinformation. For example, the subject can enter information about thesubject's lifestyle, eating and exercise habits, and how the subjectcurrently feels. Additional sensors 110, 135 can detect subject activityor other wellness information, such as respiration or pulse rates, ortemperature. In one embodiment, this subject activity and wellnessinformation is discrete information that can be measured or sensed bysensors 110, 135, as opposed to quality of life information that may beof a more general nature such as what the subject ate or how the subjectfeels, or more subjective information provided by the subject or thesubject's physician.

In one embodiment, treatment device 100 includes at least one treatmentelectrode 115 configured for external positioning proximate to thesubject. Controller 105 communicates with sensors 110, 135 includingsensors configured to sense cardiac information (e.g., cardiac sensingelectrodes) and sensors configured to detect subject activity andwellness information, (e.g., accelerometers). Controller 105 can alsocommunicate with the user interface of monitor 130. Controller 105receives detected cardiac information, (ECG signals), detected subjectactivity and wellness information, and inputted quality of lifeinformation to determine if treatment is to be applied to the subject.Controller 105 can also adjust a treatment regimen, for example byadvancing or delaying its application by treatment electrodes 115. Forexample, controller 105 can decide to apply treatment (e.g., an electricshock from therapy electrodes 115) based on sensor 110's detectedcardiac information,) and can adjust the treatment regimen based onsensor 110's detected subject activity and wellness information or basedon the quality of life information provided by or on behalf of thesubject via a user interface. In one embodiment, controller 105 adjuststherapy based on the subject's level of activity over a period of time,where information from sensors 135 is used to determine the subject'slevel of activity.

In one embodiment, controller 105 controls the nature and application ofa treatment regimen based on information from any of sensors 110, 135(including, for example, cardiac sensing electrodes, other sensingelectrodes, accelerometers), treatment electrodes 115, the userinterface of monitor 130, and other inputs of the subject's cardiacinformation, subject activity and wellness information, and quality oflife information. Based on this information, controller 105 candetermine a treatment regimen (e.g., what type of treatment) anddetermine that the treatment has, is, or will be applied. Based on thisinformation, controller 105 can also adjust the treatment regimen or theapplication of the treatment. Controller 105 can also control an alarmmodule to alert the subject or others of past, present, or pendingtreatment.

In one embodiment, medical condition sensors 110 and controller 105 candetect and identify heart failure indicators such as heart orrespiratory rates. The subject or a service provider can view a chart orgraph based on the sensed information that tracks heart failureindicators over time. The display can be on a monitor that is remotefrom treatment device 100 via wired or wireless communication over anetwork, or local to treatment device 100 as part of monitor 130.Controller 105 can generate reports that summarize trends or indicatorsfor one or more subjects. Heart failure indicators above or below acertain threshold value can trigger an alert notification to the subjectvia the alarm module or to a remote doctor. The heart failureinformation sensed by medical condition sensors 110 can be provided tothe subject or a doctor in the form of a report, either on demand orperiodically as part of a routine notification schedule. The report canbe sent by text message, page, automated phone call or email, and canflag trends in the subject's condition, noting changes, trends, andexceptions as they occur.

Subjects wearing treatment device 100 may suffer from heart failure anddevelop pulmonary edema, which involves the buildup of extravascularfluid in the lungs, (e.g., congestion). Fluid can pool in blood vesselsin the lungs and become a barrier to normal oxygen exchange. In oneembodiment, medical condition sensors 110 monitor impedance of thesubject's thoracic cavity and controller 105 processes this sensedimpedance information to detect the presence or absence of pulmonaryedema, which may be an indicator of heart failure. A reduction in sensedthoracic impedance indicates an increase in thoracic fluid, and fluiddepletion in the thorax indicates an increase in thoracic impedance.

In one embodiment, controller 105 and sensors 110 or treatmentelectrodes 115 sense and measure transthoracic impedance. This data canbe collected because the subject can wear treatment device 100substantially continuously for extended periods of time. Controller 105can average transthoracic impedance measurements over time to identifyextravascular fluid buildup. By comparing the averaged measured valueswith thresholds, treatment device 100 can alert the subject or a doctorof changes in the subject's condition so that treatment or medicaladvice can be provided.

In one embodiment, treatment device 100 measures and records respirationdata by monitoring transthoracic impedance changes. For example,impedance increases as air fills the lungs, and decreases when air isexhausted from the lungs during exhaling. By monitoring these and otherchanges with medical sensors 110 (e.g., cardiac sensing electrodes,pulse oximeters,) and activity sensors 135 (e.g., accelerometers, straingauges, pedometers, nasal clips, expandable belts, monitoring of elasticmovement of treatment device 100,) controller 105 can determine thesubject's respiration rate, stride, pulse, and other information.Information sensed by sensors 110, 135 can be transmitted over a network(e.g., the Internet) to a doctor on demand or as part of a periodicreport. The doctor can evaluate this information to make a diagnosis.

Treatment device 100 can sense and monitor a variety of conditions andtrends, such as atrial fibrillation, nocturnal heart rate, respirationrate, pulmonary sounds, heart sounds, activity trends, body positiontrends, heart rate variability, heart rate turbulence, and bradycardiaevents. For example, controller 105 can processes information detectedfrom sensors 110, 135 (e.g., ECG signals, accelerometer information, orsound information) to detect any of these conditions. In one embodiment,medical condition sensors 110 include an ECG sensing electrode systemthat, together with activity sensors 135 and controller 105, detect andrecord metrics associated with the minimum heart rate value thattypically occurs during sleep, as well as diurnal heart rate. In oneembodiment, sensors 110 include an auscultation sensor that recordschest and lung sound recordings to identify fluid content in the lungs.In addition, sensors 110 can detect wheezing and coughing that canindicate fluid buildup and a worsening condition. In one embodiment,activity sensors 135 can detect movement that occurs during coughing toverify an indication of a cough detected by an audio sensor. Controller105 may also analyze sensed heart audio signals to identify changes incardiac performance.

In one embodiment, treatment device 100 detects activity or bodyposition trends, and analyzes this information to determine thesubject's condition. Controller 100 may make this analysis, or maycommunicate the sensed information to a computer server, where theinformation is analyzed remotely. For example, the physical activity ofa subject with heart failure may decrease as the heart failure conditionworsens. General subject activity and movement can indicate whether theheart failure conditions are getting better or worsening, and canindicate whether treatment is working. For example, information fromactivity sensors 135 may be used to generate activity trends of thesubject's activity level (e.g., increasing with time, decreasing withtime, remaining substantially constant). This information can begenerated over long periods of time when the subject is wearingtreatment device 100. In one embodiment, activity sensors 135 sensesubject activity, including body movement and positioning throughout theday and during sleep. Sleep positioning information may include theangle of the subject body during sleep, as sleeping in an inclinedposition (e.g., on a reclining chair) can indicate worsening heartfailure. For example, an increasing sleep angle with time combined withdecreasing activity can indicate worsening hear failure.

Treatment device 100 may detect heart rate variability, heart rateturbulence, or bradycardia. For example, medical condition sensors 110may measure sympathetic and parasympathetic nervous system activity, andcontroller 105 may identify heart rate variability based on R-Rintervals in ECG signals or a spectral analysis of heart rate variablefrequencies. Information about these systems may be aggregated over timeto identify trends.

In one embodiment, treatment device 100 is configured for selfassessment entries by the subject. For example, a user interface thatforms part of monitor 130 can receive quality of life information suchas symptom information, body weight, and blood pressure by prompting thesubject for these entries. Other self assessment entries that includequality of life information can be provided at selectable intervals,such as daily. Examples of these questions that prompt self assessmententries include: How do you feel today? How is your breathing today? Areyou tired today? What is our weight today? What is your blood pressuretoday?

What did you eat today? The subject may select from a standard list ofresponses, for example by indicating “worse” “the same” or “better.” Thesubject may enter a number on a scale, for example from one to ten, ormay enter measured values, for example of the subject's weight or bloodpressure. In one embodiment, at least some of this information is sensedby sensors 110 or other devices, such as scales or blood pressuremonitors. The subject can enter this information over the Internet,monitor 130, or a display on a battery charger unit given to patient,for example. Interfaces used for the entry of this information may bepart of or remote from treatment device 100.

In one embodiment, wearable treatment device 100 includes biometricmonitoring of the subject wearing treatment device 100 during initialrisk assessments and during the course of treatment of a condition suchas heart failure. Treatment device 100 monitors heart failure indicatorsand the onset of symptoms, and presents this information in a selectableand customizable form to a doctor in a periodic manner, at the doctor'schoosing, or as an alert when a time sensitive condition may requirequick treatment. Treatment device 100 can present this information inthe form of aggregated reports that include trends with time of thesubject's condition. In one embodiment, this information is aggregatedin an omnibus quality of life score based on a plurality of sensedconditions. This aggregate score can be compared with a threshold valueto indicate whether or when the subject requires treatment.

In one embodiment, to gather data under controlled conditions thesubject undertakes physical activity, such as a six minute walk testthat measures how far the subject can walk in six minutes. In thisexample, the subject wears treatment device 100 during the six minutewalk test. Via monitor 130, treatment device 100 can guide or prompt thesubject throughout the test, while protecting the subject from, forexample, cardiac arrest by providing an external defibrillator. Medicalcondition sensors 110 (e.g., pulse oximeters) and activity sensors 135such as pedometers can measure the subject's distance traveled, stridedistance, respiration, heart rate, ECG, blood oxygen saturation, andrecovery time before, during, and after the six minute walk test. Thedoctor can use this information to evaluate a treatment regimen or trackthe subject's progress. For example, the six minute walk test can beadministered before and after changes to the subject's treatment regimento evaluate the subject's progress and the efficacy of treatment. In oneembodiment, the six minute walk test is modified to determine energyspent by the subject during the six minute walk, for example based on x,y, and z direction accelerometer measurements taken during the test. Thesubject can wear treatment device 100, and treatment device 100 canapply treatment to the subject, during the test. In one embodiment,treatment device 100 tracks the subject's exercise regimen. For example,when the exercise is walking, cycling, or aerobic activity, treatmentdevice 100 tracks duration, distance covered, heart rate, date,respiration rate, transthoracic impedance, walking angle, heart ratevariability, time spent exercising, the subject's ECG, and post-exerciserecovery time. Treatment device 100 can capture this informationcontinuously during exercise and can present this information to adoctor for analysis and record keeping. In one embodiment, treatmentdevice 100 alerts the subject that it is time to exercise at adetermined date or time. Treatment device 100 may also identify a targetheart rate (or range) and prompt the subject in real time to exercisewith greater or lesser intensity in order to maintain a heart ratesubstantially at the target heart rate and to properly warm up and cooldown before and after exercising. The target range can be adjusted basedon information provided by sensors 110, 135.

Throughout the exercise regimen, treatment device 100 can monitor,record, and report information related to the subject's activitytogether with date and time information. Reports or summaries of thissubject activity can be provided to a doctor, and can flag for thedoctor's attention any conditions or changes that may have occurredduring exercise. Treatment device 100 may also act as a diet monitorthat sets up and tracks the subject's eating habits. This informationcan be reported to a doctor. In one embodiment, treatment device 100monitors a treatment regimen that includes special dietary guidelines,such as a low fat, low calorie, or low salt diet. The subject can enterinformation about the food the subject is eating in real time, via auser interface of monitor 130. In one embodiment, the user interfaceincludes a bar code scanner to scan packaged food bar codes and retrievetheir nutritional information from a database. In some embodiments,treatment device 100 monitors the subject's diet and weight in paralleland adjusts a recommended diet regimen of the subject to adjust ormaintain the subject's weight. For example, treatment device 100 cannormalize food intake to overall subject energy, deduced by controller105 from accelerometer readings, over a period of time to identify adiet regimen.

Further examples of the information sensed and evaluated by thecomponents of wearable treatment device 100 include the following:

Subject Movement During Arrhythmia

Activity sensors 135, such as an accelerometer can be used to determinea subject's body state during the detection of an arrhythmia. They canalso be used to detect if a mechanically noisy environment is the causeof erroneous arrhythmia detection.

Subject Movement used in the Confidence Algorithm Factor

In one embodiment, a confidence algorithm, which can be influenced bymany inputs including the subject's body state as determined by activitysensors 135, is used to determine if a subject's heart arrhythmiasrequires defibrillation by treatment device 100.

In one embodiment, cardiac treatment is not required if the subject isconscious and occurs only when the subject is unconscious. By usingactivity sensors 135 the subject body state can be monitored. In oneembodiment, when there has been no change in subject body state for aperiod of time as detected by activity sensors 135 then there will be anincreased confidence of the algorithm that the subject is unconscious.For example, if a change in subject body state is detected by activitysensors 135, such as an accelerometer, then there will be a decreasedconfidence of the algorithm that the subject is unconscious. Treatmentdevice 100 can adjust the treatment regimen to, for example, hasten theapplication of treatment if a high level of confidence exists that thesubject is unconscious. If subject motion is detected while othersensors 110 and algorithms processed by controller 105 indicate that atreatable rhythm is present, treatment delivery can be delayed toprovide the subject additional time to respond to system messaging.

False Arrhythmia Detection due to Physical Motion

Controller 105 can detect a false arrhythmia due to physical motion. Forexample, sensors 110 or wire 125 can move against the body or clothing,creating false deviations in the subject's ECG. If an arrhythmia isdetected and vibration or high subject/equipment acceleration isdetected, then the subject can be alerted to this condition. Monitor 130or an alarm module can notify the subject. This information may also beapplied to the treatment confidence algorithm thereby causing a decreasein confidence given that the physical motion can cause a false positivedetection. Use of activity sensors 135 can reduce undesired treatment offalse arrhythmias.

Correlation of ECG Artifact with Belt Motion

Motion of the belt or other treatment device 100 component may causeinterference with ECG signal pickup and possible false detections. Thesignals obtained from activity sensors 135 or other sensors 110 can becorrelated with an ECG signal to determine if ECG signal contaminationexists. The quality of the correlation can be used by controller 105 asan additional confidence factor in the arrhythmia detection algorithm Ifan arrhythmia is detected and there is a high degree of correlationbetween the ECG signal and a signal from activity sensor 135, theconfidence in the arrhythmia detection can be reduced. No signalcorrelation indicates increased confidence that the arrhythmia detectionis accurate.

Treatment Verification

Activity sensors 135, such as accelerometers may also be used to verifythat a treatment has been applied by detecting sudden movements ormuscle spasms in the subject immediately following the treatment. Oftenafter defibrillation the subject's muscles spasm from the energy pulse.The muscle spasm can cause detectable movements on activity sensors 135similar to convulsing.

Detection of Bystanders/Unsuccessful Defibrillation

Post shock motion of the subject after several unsuccessfuldefibrillation attempts may indicate the presence of bystanders. Thebystanders could be rescue personnel such as an EMT. In this casemonitor 130 or an associated alarm module can generate audio or visualalarms or voice messages to inform the bystander of the equipment andtreatment status. Controller 105 can adjust the timing of additionalshocks (for example by delaying or canceling them) to prevent a shock tothe bystanders or rescue personnel.

Post Shock Motion Detection

When a shock is delivered, the subject may move suddenly and then returnto a state where there is a lack of motion. If no further motion isdetected, controller 105 can determine with a high confidence level thatthe arrhythmia is still present. This information can be used bycontroller 105 as an additional post-shock confidence factor for thedetection algorithm and that a continuing cardiac condition exists. Ifpost-shock motion continues or if the subject body position changes froma horizontal to vertical position, controller 105 can determine thatthere is high confidence that the defibrillation was successful andadditional shocks or other treatment can be delayed. Based on post shockmotion, treatment device 100 can also detect and control pacing of thesubject.

Belt Quality Feedback

Treatment device 100 may include a belt for proper positioning on thesubject and to house treatment device 100 components. Overall beltquality can be examined by gathering data using activity sensors 135during certain failure states such as sensor 110 fall-off and treatmentelectrode 115 fall-off detection.

Reduce Electrode and Therapy Pad Fall-Offs

If one of sensors 110 or treatment electrodes 115 fall off of thesubject, controller 105 can record the subject's body state during thefall-off event based on information from sensors 110, 135 or informationinput by the subject via a user interface. Subject positions includesitting up, lying down; left side, right side. If controller 105identifies vibration or the subject falling then that information can berecorded and evaluated by controller 105 since it might be the cause ofthe falloff event. Over time, controller 105 can use this information todetermine positions that may tend to cause fall-offs of treatment device100 components. This information can then be used to improve the beltdesign reducing and possibly eliminating the fall-offs in those certainactivities or positions. This information can also be used to train thesubject and those assisting the subject as to how to wear and usetreatment device 100 and its components, as well as to establishinstructions for future use of treatment device 100. An example would beif post analysis of data over a several month period of time shows that75% of ECG fall-offs occur when the subject is laying on their left sidethen the belt design on the left side could be examined to determinewhat might be making it susceptible to fall-offs in that subjectposition.

Provide Recommendations to Subjects

Activity sensor 135 data collected over time could also be used toinform subjects of body states that tend to be more comfortable.Subjects who have worn the device for an extended time will most likelyhave experimented with different positions (sleeping positions, sittingpositions, etc.) and will tend to use the most comfortable ones. Thisdata can be provided to controller 105, stored, and used to improve thebelt for the other positions and also provide recommendations to newsubjects.

Improve Belt Comfort

Data collected by sensors 110 during subject use can be used to improvethe comfort of the treatment device 100 when worn by studying subjectsleep habits, or habits during other selected activities. For example,if 80% of the subjects tend to sleep on their right side then theassumption can be made that something about the belt makes it lesscomfortable for the subjects to lie on their left side. With thisinformation controller 105 can determine what about that position causesthe belt to be uncomfortable and engineering can be performed to improvetreatment device 100 comfort.

Belt Self Diagnostics

Self diagnostics may also be provided such as a Belt Node TactileStimulator (vibration/acceleration) self test. For example, treatmentdevice 100 may include a tactile stimulator or other subjectnotification device. The tactile stimulator may include a motor with anunbalancing weight on its shaft. When the motor is on, it causes thebelt to vibrate much like a cell-phone in vibration mode. When thetactile stimulator is activated, an activity sensor 135, such as anaccelerometer in node 120 can detect vibrations from the tactilestimulator to verify that node 120 is vibrating and that the tactilestimulator is working. The tactile stimulator can be housed in node 120,with monitor 130, or the alarm module.

Subject Notification of Physical Events

Controller 105 can use activity sensor 135 information to providefeedback to the subject regarding mechanical events, or to adjust audiovolume outputs of the alarm module or monitor 130 based on the currentstate of the subject.

Equipment Abuse Notification

If certain mechanical conditions that may lead to equipment damage suchas mechanical shock or vibration are detected by activity sensors 135then the controller 105 can instruct monitor 130 or the alarm module tonotify the subject of such conditions and advise the subject of thecondition.

If monitor 130 or belt is dropped, or if they are hit with some otherobject causing a force greater than a predefined acceptable force, thenmonitor 130 or the alarm module can provide an audio, visual, or hapticindication to the subject that the event has occurred and warn againstallowing such an event to occur again.

If continuous vibration above a certain predefined acceptable thresholdis detected for a period of time, then monitor 130 or the alarm modulemay also provide a warning to the subject. Such vibration could lead tosensor 110 or treatment electrode 115 fall-off, or even cause falsearrhythmia detection if enough physical motion is applied to the sensors110, treatment electrodes 115, wires 125, or other components.

Adjust Device Alarm Volumes

If information from activity sensors 135 indicates that the subject'sbody state is unchanged for a period of time, and the subject is eitherlying or sitting down then controller 105 can determine that the subjectis sleeping and can increase the audio volume output of any audiomessage if necessary to awaken the subject. Controller 105 may alsoenable the tactile stimulator to awaken the subject in the event of acritical audio message.

Adjust Display Rotation

Information from activity sensors 135 can be used by controller 105 todetermine the proper position of monitor 130 to deliver a visual messageto the subject or for initial subject setup by care givers. For visualmessages to the subject, since monitor 130 can be positionedapproximately at the subject's mid section, the display of informationby monitor 130 may appear upside down (rotated 180 degrees) with respectto monitor 130. However, during setup, when the subject is fitted withtreatment device 100 and when its components are positioned, monitor 130could be held right side up in front of the skilled personnel. As aresult, the display would be right side up.

Detect Equipment Abuse

Controller 105 can detect abuse of treatment device 100 and itscomponents during use as well as during shipping. This abuse can bedetermined by parameters such as number of times dropped and intensity.Detection of abuse can trigger such actions as internal diagnostics,auto download, and equipment service recommendations.

Equipment Drop Detection

If activity sensors 135 detect a mechanical shock, for example tomonitor 130 above a pre-determined acceptable threshold, then controller105 can identify and record a drop event. Other parameters such asdate/time stamp and current operating mode can be identified andrecorded as well. The date/time stamp can allow correlation betweenmonitor 130 location and the damaging event allowing further informationto be obtained using the carrier tracking numbers if such damageoccurred during shipping.

If it is not during shipping and is during use of treatment device 100by the subject, and there is some form of treatment device 100malfunction after the drop then that could be tied to the root cause ofthe equipment failure. Such information could be used to advise subjectsof the types of mechanical shocks that may damage the equipment orcomponents of treatment device 100. It also may be used to improve therobustness of the equipment to survive such forces in the future.

Equipment Service Recommendation

If activity sensors 135 records a mechanical shock above a predefinedacceptable threshold, or if a predefined acceptable number of mechanicalshocks have occurred, monitor 130 can display a message indicating thatthe equipment should be serviced. Controller 105 can also, during thenext download, notify the manufacturer that treatment device 100 shouldbe serviced.

Internal Diagnostics

Logic devices that are part of activity sensor 135, monitor 130, or node120 may constitute at least part of controller 105. If activity sensor135 does detect an excessive mechanical shock on the belt or monitor 130then controller 105 may initiate internal self-diagnostics. Activitysensor 135, monitor 130, and node 120 may include circuitry to allowmost of its components to be tested with self diagnostics.

Auto Download to Manufacturer

If there is a significant mechanical shock to treatment device 100components or equipment such as the belt or monitor 130, then controller105 may communicate with the manufacturer via a communications networkto request service.

Monitor Subject Activity over Time

Data provided by activity sensor 135 or medical condition sensors 110can be measured and stored over time to study subject activity. Subjectactivity data can be used to provide feedback to doctors about asubject's specific condition.

Subject Activity Data and Treatment

After applying treatment, subject activity data taken before, up to, andincluding the event can be downloaded from treatment device 100 to aremote data storage unit. This information can also be recorded locallyat treatment device 100. This data can be collected among a plurality ofsubjects and used to make correlations between subject activity derivedfrom sensors 110 and the probability of a cardiac event or othercondition that requires treatment occurring. These correlations can beused to take precautionary measures with subjects who have similaractivities as those who had past treatment events.

Subject Activity Data and Doctor Feedback

Subject activity data can be used over a period of time by doctors ordata evaluation systems to determine if proper subject activity levelsare met. For example, a doctor can analyze the data to determine thatthere is low subject activity, or that the subject is performingrecommended exercises. The doctor can also monitor the subject's realtime activity level and corresponding heart rate data. Subjects who areexperiencing congestive heart failure can be monitored for physicalactivity and at rest body position. Gradual reduction in subjectactivity indicated by lack of motion can indicate a worsening of thecongestive heart failure condition. Body position at rest can alsoindicate subject deterioration if body position at rest is primarilyvertical since congestive heart failure subjects may have difficultyresting in a horizontal position.

FIG. 6 depicts a flow chart for a method 600 of monitoring and treatinga subject. In one embodiment, method 600 includes an act of sensingcardiac information of a subject (ACT 605). For example, sensing cardiacinformation (ACT 605) may include detecting ECG (electrocardiogram)signals or other information related to electrical or mechanicalactivity of the subject's heart. In one embodiment, dry externalelectrodes are configured external to the subject to sense (ACT 605)cardiac information. Internal electrodes may be used as well. Sensorsused to sense (ACT 605) cardiac information can be part of a wearablesubject treatment device that includes an external defibrillator. In oneembodiment, sensing cardiac information (ACT 605) includes sensinginformation indicative of heart failure or other medical conditions.

In one embodiment, method 600 includes the act of sensing at least oneof subject activity and wellness information (ACT 610). For example,internal or external sensors proximate to the subject's body can sense(ACT 610) pulse, breathing, temperature, blood pressure, or fatigueinformation, for example. In one embodiment, sensing activity andwellness information (ACT 610) includes detecting subject movement, lackthereof, position, or orientation. Sensing activity or wellnessinformation (ACT 610) may include detecting tangible medical or physicalcondition or information indicative of a subject's overall health, aswell as changes in health-related measurements or conditions with time.

Method 600 may also include at least one act of receiving quality oflife information (ACT 615). The quality of life information may bereceived from the subject, or on the subject's behalf from a physicianor someone acting on the subject's behalf. In one embodiment, quality oflife information is received (ACT 615) by a user interface of a wearabletreatment device. For example, the quality of life information may bereceived (ACT 615) via direct manual entry into the user interface, orremotely via one or more wired or wireless networks. Receiving qualityof life information (ACT 615) may include receiving information aboutthe subject's lifestyle, such as dietary, activity, or exercise habits,when the subject last took a particular action, or information about howthe subject feels.

In one embodiment, method 600 includes acts of determining whether ornot treatment is to be applied (ACT 620) and adjusting the determinedtreatment (ACT 625). For example, treatment (e.g., an electric shock)can be determined to be applied (ACT 620) based on the detected (ACT605) cardiac information. In this example, sensed (ACT 605) cardiacinformation may indicate that the subject is experiencing a cardiacevent and in need of pacing or defibrillation. Adjusting the treatment(ACT 625) may include time shifting the application of the treatment, ordelaying application of the treatment pending confirmation of thesubject's condition, based on the subject's sensed (ACT 610) activityand wellness information. For example, method 600 can determine (ACT620) that treatment is not to be applied due to a high heart beat, whensensed (ACT 610) subject activity and wellness information indicatesthat the subject is intensely exercising, and that this may be the causeof the elevated heart beat. In this example, application of pacing orother treatment can be delayed (ACT 620) until it is determined that thesubject is no longer exercising yet still has an elevated heart rate.

In one embodiment, method 600 includes an act of providing an alarm (ACT630). For example, an alarm can be provided (ACT 630) by alerting thesubject or other person of treatment. The alarm may be audio, visual,haptic, or combinations thereof, and can alert the subject and others inthe vicinity of the subject of a treatment regimen. In one embodiment,providing the alarm (ACT 630) includes alerting a doctor or health careprovider that treatment has, is, or will be applied to a subject wherethe doctor is located remotely from the subject. For example, the alarmmay be provided (ACT 630) when the subject is on the street, or at home.In this example, the alarm can be provided remotely via wired orwireless communications through a communications network to the doctorwho may be present in a hospital or office.

In some embodiments, providing the alarm (ACT 630) includes alerting thesubject or other person of a treatment regimen subsequent to sensing thesubject's cardiac information (ACT 605). Providing the alarm (ACT 630)may also include alerting the subject or other person of a treatmentregimen prior to an act of applying treatment to the subject (ACT 635).In one embodiment, applying treatment to the subject (ACT 635) includesapplying an electrical shock or current to the subject as part of adefibrillation or pacing treatment regimen. In some embodiments,applying treatment (ACT 635) occurs subsequent to the act of alertingthe subject or another person that treatment has been applied, is beingapplied, or will be applied.

FIG. 7 depicts a flow chart for a method 700 of monitoring and treatinga subject. In one embodiment, method 700 includes an act of providingthe wearable treatment device (ACT 705). For example, providing thedevice (ACT 705) may include providing a garment in the general form ofa vest or shirt that may include at least one strap, belt, pocket orreceptacle. In one embodiment, providing the wearable treatment device(ACT 705) includes providing a device that includes a cardiac sensingelectrode to detect cardiac information (e.g., ECG) of the subject, anda treatment electrode to apply electric current to the subject as partof, for example, a defibrillation or pacing treatment. Providing thedevice (ACT 705) may also include providing a user interface to receivequality of life information from the subject. This may include factualdata about the subject's lifestyle, as well as the subject's opinion asto how the subject feels or the subject's health. Providing the device(ACT 705) may also include providing a garment with an activity sensor,such as one or more motion sensors or accelerometers to detect subjectactivity and wellness information indicative of a general wellness ofthe subject.

In one embodiment, providing the device (ACT 705) includes providing acontroller. The controller communicates with the cardiac sensingelectrode, the treatment electrode, the user interface, and the sensorto receive the detected cardiac information, the quality of lifeinformation, and the detected subject activity and wellness information.The controller can also determine that treatment is to be applied to thebody of the subject based upon the detected cardiac information, and canadjust the treatment based on at least one of the detected subjectactivity and wellness information and the quality of life information.In one embodiment, providing the device (ACT 705) includes providing analarm module. The alarm module can provide an alarm to indicatetreatment has, is, or will be applied to the body of the subject.

In one embodiment, method 700 includes an act of providing instructions(ACT 710). This may include providing instructions to operate thewearable treatment device. For example, providing instructions (ACT 710)can include providing at least one instruction to position at least oneof the cardiac sensing electrode, the therapy electrode, and theactivity sensor on the subject, and any other device components on thesubject. Providing instructions (ACT 710) may also include providinginstructions to wear or position the wearable treatment device or any ofits components on the subject.

Having now described some illustrative embodiments of the invention, itshould be apparent to those skilled in the art that the foregoing isillustrative and not limiting, having been presented by way of example.In particular, although many of the examples presented herein involvespecific combinations of method acts or system elements, it isunderstood that those acts and those elements may be combined in otherways to accomplish the same objectives. Acts, elements and featuresdiscussed only in connection with one embodiment are not intended to beexcluded from a similar role in other embodiments.

Note that in FIGS. 1 through 7, the enumerated items are shown asindividual elements. In actual implementations of the systems andmethods described herein, however, they may be inseparable components ofother electronic devices such as a digital computer. Thus, actionsdescribed above may be implemented at least in part in software that maybe embodied in an article of manufacture that includes a program storagemedium. The program storage medium includes data signals embodied in oneor more of a computer disk (magnetic, or optical (e.g., CD or DVD, orboth)), non-volatile memory, tape, a system memory, and a computer harddrive.

From the foregoing, it will be appreciated that the wearable treatmentdevice described herein is worn by the subject and senses informationabout the subject's activity, wellness, and quality of life via directsensing or user provided data entries. The treatment device candetermine if treatment is needed based on the subject's physicalcondition, can adjust treatment regiments based on sensed information,and can apply treatment to the subject as necessary. The wearabletreatment device can gather information about the subject's health inreal time over a substantially continuous period. This information canbe aggregated to form a comprehensive medical history of the subject,which can be used to determine if past treatment regimens are successfuland if modifications should be made.

Any embodiment disclosed herein may be combined with any otherembodiment, and references to “an embodiment,” “some embodiments,” “analternate embodiment,” “various embodiments,” “one embodiment” or thelike are not necessarily mutually exclusive and are intended to indicatethat a particular feature, structure, or characteristic described inconnection with the embodiment may be included in at least oneembodiment. Such terms as used herein are not necessarily all referringto the same embodiment. Any embodiment may be combined with any otherembodiment in any manner consistent with the aspects and embodimentsdisclosed herein.

Publications, patents, and patent documents referred to in this documentare incorporated by reference herein in their entirety, as thoughindividually incorporated by reference. In the event of inconsistentusages between this document and those documents so incorporated byreference, the usage in the incorporated references is supplementary tothat of this document; for irreconcilable inconsistencies, the usage inthis document controls.

References to “or” may be construed as inclusive, so that any termsdescribed using “or” may indicate any of a single, more than one, andall of the described terms.

Where technical features in the drawings, detailed description or anyclaim are followed by reference signs, the reference signs have beenincluded for the sole purpose of increasing the intelligibility of thedrawings, detailed description, and claims. Accordingly, neither thereference signs nor their absence have any limiting effect on the scopeof any claim elements.

One skilled in the art will realize the systems and methods describedherein may be embodied in other specific forms without departing fromthe characteristics thereof. For example, the wearable treatment devicecan be used outside a hospital setting to protect the subject, applytreatment, and create medical history simultaneously. The wearabletreatment device may also include a series of electrodes and otherelements that are disposed about the subject and do not constitute anactual garment. The foregoing embodiments are illustrative rather thanlimiting of the described systems and methods. Scope of the systems andmethods described herein is thus indicated by the appended claims,rather than the foregoing description, and changes that come within themeaning and range of equivalency of the claims are embraced therein.

What is claimed is:
 1. A wearable monitoring device, comprising: aplurality of cardiac sensing electrodes configured to be positionedoutside a body of a subject and to detect cardiac information of thesubject; a monitor configured to administer a predetermined test to thesubject and having a user interface configured to receive quality oflife information from the subject; at least one motion sensor configuredto be positioned outside the body of the subject and to detect subjectmotion during the predetermined test; and a controller communicativelycoupled to the plurality of cardiac sensing electrodes, the monitor, andthe at least one motion sensor, the controller configured to receive andstore the detected cardiac information, the quality of life information,and the detected subject motion, and to communicate the stored detectedsubject motion and the quality of life information to a remote computer.2. The wearable monitoring device of claim 1, wherein the quality oflife information identifies at least one of a fatigue level and abreathing level of the subject.
 3. The wearable monitoring device ofclaim 1, wherein the quality of life information identifies informationabout at least one of the subject's lifestyle, body weight, bloodpressure, eating and exercise habits, symptom information, fatigueinformation, breathing level and how the subject currently feels.
 4. Thewearable monitoring device of claim 3, wherein the predetermined test isa six minute walk test.
 5. The wearable monitoring device of claim 4,wherein the at least one motion sensor includes at least oneaccelerometer.
 6. The wearable monitoring device of claim 5, wherein thecontroller determines a distance travelled by the subject during the sixminute walk test based upon the detected subject motion from the atleast one accelerometer.
 7. The wearable monitoring device of claim 6,further comprising at least one additional sensor communicativelycoupled to the controller to detect at least one of blood pressure,blood oxygen level, respiration, and temperature.
 8. The wearablemonitoring device of claim 7, wherein the controller wirelesslycommunicates the stored detected subject motion and the quality of lifeinformation to the remote computer.
 9. The wearable monitoring device ofclaim 4, wherein the at least one motion sensor includes a pedometer,and wherein the controller determines a distance travelled by thesubject during the six minute walk test based upon the detected subjectmotion from the pedometer.
 10. The wearable monitoring device of claim4, further comprising at least one additional sensor communicativelycoupled to the controller to detect at least one of blood pressure,blood oxygen level, respiration, hypovolemia, and temperature.
 11. Thewearable monitoring device of claim 4, wherein the quality of lifeinformation further includes information about at least one of thesubject's lifestyle, body weight, blood pressure, eating and exercisehabits, symptom information, fatigue information, and how the subjectcurrently feels.
 12. The wearable monitoring device of claim 1, whereinthe predetermined test is a six minute walk test, and wherein the atleast one motion sensor includes at least one accelerometer.
 13. Thewearable monitoring device of claim 12, further comprising at least oneadditional sensor communicatively coupled to the controller to detect atleast one of blood pressure, blood oxygen level, respiration,hypovolemia, and temperature.
 14. The wearable monitoring device ofclaim 1, wherein the predetermined test is a six minute walk test, andwherein the at least one motion sensor includes a pedometer.
 15. Thewearable monitoring device of claim 1, wherein the predetermined test isa six minute walk test, and wherein the at least one motion sensorincludes at least one of an accelerometer and a pedometer.
 16. Thewearable monitoring device of claim 15, wherein the user interface isconfigured to guide the subject through the predetermined test.
 17. Thewearable monitoring device of claim 15, further comprising at least oneadditional sensor communicatively coupled to the controller to detect atleast one of blood pressure, blood oxygen level, respiration,hypovolemia, and temperature.
 18. The wearable monitoring device ofclaim 1, wherein the quality of life information identifies a fatiguelevel and a breathing level of the subject.
 19. The wearable monitoringdevice of claim 18, wherein the quality of life information is receivedfrom the subject in response to questions posed to the subject via theuser interface of the monitor.
 20. The wearable monitoring device ofclaim 1, wherein the quality of life information is received from thesubject in response to questions posed to the subject via the userinterface of the monitor.
 21. The wearable monitoring device of claim20, wherein the questions are posed to the subject at selectableintervals.
 22. The wearable monitoring device of claim 1, wherein theuser interface is configured to guide the subject through thepredetermined test.
 23. The wearable monitoring device of claim 1,wherein the user interface is configured to prompt the subject toperform the predetermined test.
 24. The wearable monitoring device ofclaim 1, wherein the user interface is configured to prompt the subjectto provide the quality of life information.
 25. The wearable monitoringdevice of claim 1, further comprising at least one additional sensorcommunicatively coupled to the controller to detect the subject's bodyposition.
 26. The wearable monitoring device of claim 25, furthercomprising detecting the subject's body position in one of an uprightposition and a prone position, and detecting that the subject is asleep.27. The wearable monitoring device of claim 1, further comprising atleast one additional sensor communicatively coupled to the controller todetect at least one of sleep apnea, wheezing, and coughing.
 28. Thewearable monitoring device of claim 1, further comprising at least oneadditional sensor communicatively coupled to the controller to measureimpedance of the subject's thoracic cavity.
 29. The wearable monitoringdevice of claim 1, wherein the quality of life information identifiescompliance with a prescribed treatment.
 30. The wearable monitoringdevice of claim 1, wherein the quality of life information identifiesnutritional content of a food item, wherein the user interface furthercomprises a bar code scanner configured to scan a bar code of a fooditem, and wherein the controller is further configured to accessinformation about the nutritional content of the food item withreference to the bar code.